GxP in Pharmaceuticals

GxP refers to the “Good Practices” whose rulings are observed in the pharmaceutical industry. This body sets the standard that all pharmaceutical companies should abide by, in order to continue conducting business. GxP is the overall regulation and includes various sections including, Good Laboratory Practice (GLP), Good Automated Manufacturing Practice (GAMP) and Good Clinical Practice (GCP). GxP is used across many fields and most especially in the food industries.

Initiated in 1979, (GLP) is focused on the organization’s, process and conditions for laboratory studies. GLP ensures that the studies that are performed are monitored, recorded and reported. The main objective of this is to ensure that the highest level of quality and standards are adhered to, as well as the traceability and the integrity of the data.

GMP is enforced by the US Food and Drug Administration (FDA) and refers to the systems in place that assure monitoring, control of manufacturing processes and proper design. These regulations ensure the identity, quality, strength and purity of the products manufactured.

The FDA is a federal agency of the United States Department of Health and Human Services and is responsible for protecting and promoting public health. They administer, control and supervise food safety, dietary supplements, prescriptions and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, tobacco products, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods and feed and veterinary products. Formed in the late 19th century, the FDA has strict standards and regulations.

Provided by the international body that defines standards – the International Conference on Harmonization (ICH) – GCP is an international ethical and scientific standard for reporting, conducting and recording all studies that require human participants.

The US pharmaceutical market is estimated at over $300 Billion per year, and is one of the most valued industries today, with the human race heavily relying on medications to combat terminal diseases like cancer. GxP is vital to ensure that companies in the pharmaceutical industry conduct themselves in a manner that is professional and ethical. Working and mixing different compounds and creating drugs for human consumption is a delicate science and if certain standards and guidelines are not followed, it could lead to the death of many individuals.

Archiving is extremely vital to the GxP process and companies are required to keep all documented information, without ever deleting or erasing these documents, until the drug has been entirely removed from the market.

The main purpose of GxP is to ensure that any and all drugs and medications created are safe for human consumption and that it actually does what the pharmaceutical company claims. Central to the GxP process is that all pharmaceutical companies are required to prove the manufacturing process of a drug, detailing all elements and ingredients and the development procedure of the drug. Detailed documentation, research and reports are mandatory for each and every drug that is manufactured. Secondly and most importantly, the organization must accept accountability if something does go wrong with any of its products. If an individual claim that a product can be found to do more harm than good, it is up to the pharmaceutical company to go through the process of in-depth investigations of the development of the drug, resulting in an unbiased and true conclusion.

Due to the level of risk involved, pharmaceutical follows a more rigorous GXP than any other industry. A technically advanced IT auditing system must be in place to be able to back-track and trace the development path and processes, should a dispute arise.

In recent years, because of fast-paced, technological advancement, the FDA have started imposing much stricter regulations in terms of the GxP. There is no room for error in this industry and organization trade on their credibility and cannot afford to be publicly exposed for negligence, as this could cost them billions of dollars and puts a big risk on the entire business. The world’s largest pharmaceutical companies have paid almost $10.5 Billion in lawsuit settlements. In 2010, many of the top pharmaceutical companies were heavily penalized for withholding health risks of their medications and for manufacturing defective medical devices.

GxP in pharmaceuticals does not only protect the consumer, but it also protects the pharmaceutical companies and is in their best interest to adhere to the strict guidelines. Ensuring that everything is documented, means that the organization minimizes risk to themselves. Should a complaint be lodged against a company, it would be easy for them to retrieve the processes and followed during the creation of the drug.